Altamira updates Bentrio EU roll-out, 510(k), new Asian distribution, COVID-19, allergy testing

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Altamira Therapeutics (NASDAQ:CYTO) issued a business update on Bentrio, its nasal spray for protection against airborne viruses and allergens.

  • The company has set up contracts with wholesalers in its lead market of Germany that cover more than 50% of German pharmacies, representing the vast majority of the OTC market in Germany. Sales are increasing steadily and are expected to be boosted further through various marketing initiatives planned for the first quarter of 2022. Bentrio also has become available in Germany on the Amazon platform, further strengthening the product’s online channel presence. The Amazon platform will be expanded to other European markets. In Switzerland, Bentrio will become available in early January under a distribution agreement with Akos Santé.
  • The FDA started the substantive review of the company’s 510(k) application for premarket clearance for protection against airborne allergens in mid-October. As part of the review process, Altamira has been in dialogue with the agency and is looking forward to continuing working with it, aiming to make Bentrio available to people suffering from allergic rhinitis in the U.S.
  • Altamira and Wellesta Holdings of Singapore, entered into a definite Bentrio marketing and distribution agreement for six Asian countries: India, Indonesia, Malaysia, Singapore, Taiwan and Vietnam. Wellesta already has obtained the first of the national registrations for Bentrio in its sales territory. Based on various ongoing discussions, Altamira expects to expand the geographic footprint for Bentrio further through agreements with additional international distributors.
  • Following successful testing of Bentrio against the Delta variant of SARS-CoV-2 in a human nasal epithelia model, the company is now planning to evaluate the product’s effectiveness against the Omicron variant. Given the broad applicability of Bentrio, Altamira also expects to observe protective effects in this assay against this new and fast-spreading variant.
  • Preparations to conduct a clinical trial for COVID-19 to further confirm the efficacy and safety of Bentrio are progressing. Following formal classification of Bentrio as a medical device, the trial application is now going through the regular approval process with the Drugs Controller General of India. In addition, Altamira has decided to broaden the geographic scope of the study and include two countries in Southeast Europe for which trial applications will be submitted shortly under fast track conditions.
  • In recent weeks, two clinical trials with Bentrio started enrolling patients suffering from allergies due to airborne allergens. In the NASAR trial, Altamira plans to enroll 100 patients suffering from seasonal allergic rhinitis for a two-week treatment course, and in the second trial, 36 patients suffering from perennial allergic rhinitis due to house dust mite exposure. Results from the studies are expected in the first half of 2022.

In a statement, Thomas Meyer, founder, chairman and CEO of Altamira, said the rapid and global spread of the Omicron variant of SARS-CoV-2 is highlighting once more the need for simple, yet versatile protective measures to complement classic approaches, such as vaccination, protective mask wearing or social distancing.